A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986521 in Healthy Participants.

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986521 following single and multiple ascending doses of BMS-986521 in healthy adult participants, and to evaluate potential food effects on BMS-986521 exposure.

Key facts

Study ID

NCT07283263

Run by

Bristol-Myers Squibb

People needed

106

Starts

2025-12-23

Expected to finish

2026-11-17

Last updated by the study team

2026-01-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants must be healthy males and females (assigned at birth) who are not of childbearing potential, with no clinically significant abnormalities in medical history, physical exam, ECG, or lab tests.
• Participants must have a body mass index (BMI) between 18 and 32 kg/m² (inclusive) and body weight of at least 50 kg.
• For Part B/Cohort 11 only: participants with stable cardiovascular conditions may be included if deemed suitable by the investigator.

You may not qualify if…

• Participants must not have any significant medical condition or history (renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic) that may affect drug absorption, distribution, metabolism, or excretion (ADME), or pose a risk to the participant.
• Participants must not have a history of rhabdomyolysis, cancer (except certain cured skin or cervical cancers), hematologic malignancy, or myelodysplastic syndrome.
• Participants must not have recent or current significant GI disease, major surgery, or medical interventions affecting ADME (except appendectomy or cholecystectomy).
• Participants must not have had a blood transfusion within 4 weeks or have an inability to tolerate oral medication or venous access.
• Other protocol defined inclusion/exclusion criteria apply.

Where it is running

• CenExel ACT (Formerly Anaheim Clinical Trials; LLC) — Anaheim, California, United States (enrolling)

Full record on ClinicalTrials.gov

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